Patient Access to Epidural Steroid Injections Preserved
Tuesday, October 20, 2015
On October 7, 2015, a long-awaited Food and Drug Administration (FDA) response to the recommendations made by the Anesthetic and Analgesic Drug Products Advisory Committee in November 2014 was published in the New England Journal of Medicine.
SIS is very pleased that, after our painstaking efforts to prevent a new contraindication restricting the injection of glucocorticoids into the epidural space, the FDA decided not to proceed with such a contraindication. Our gratitude goes to Dr. Ray Baker for representing SIS at the FDA Advisory Committee meeting and all the Multi-Society Pain Workgroup (MPW) specialty societies who worked with us to provide the FDA with the information necessary to ensure that patients will continue to have access to these critical procedures.
We are disappointed that the FDA has concluded that there will be no change to the current warning about serious neurologic events and that the warning will not be amended to include only particulate steroids injected via the transforaminal route.
SIS continues to stand by and encourage implementation of the MPW recommendations that were developed in collaboration with the FDA Safe Use Initiative. The recommendations address critical clinical considerations aimed at ensuring the safety of these procedures.